Central Venous to Arterial CO2 Difference and Low Cardiac Output Syndrome Related Outcomes in Children After Cardiac Surgery (VACO2)

Predictability of Central Venous to Arterial CO2 Difference (AVCO2) in Children With Cardiac Surgery to Poor Outcomes

The goal of this clinical trial is to compare the capability of 3 different bedside surrogates in children who underwent cardiac surgery and were admitted in intensive care unit. These test are lactate, oxygen saturation from central venous and the carbon dioxide gap between central venous and arterial.

The main questions is which one is the best prognostication for post operation poor outcomes Participants will be taken routine blood test for post cardiac care (at ICU arrival, 6, 12, and 24 hour post operation) and follow the their outcomes. There is no any intervention or drug in this research

Study Overview

• Status: Completed
• Conditions: Congenital Heart Disease; Perioperative/Postoperative Complications; Lactate Blood Increase
• Intervention / Treatment: Diagnostic test: arterial and central venous blood gas analysis, lactate

• Study Type: Observational
• Enrollment (Actual): 136

Contacts and Locations

Study Locations

• Thailand
  • Songkhla
    • Hat Yai, Songkhla, Thailand, 90110
      • Faculty of Medicine, Prince of Songkla University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Children with cardiac disease in Songklanagarind hospital who undergone open cardiac surgery with cardiopulmonary bypass (age < 18 years old)

Description

Inclusion Criteria:

• Children aged 0-18 years old with either congenital or acquired cardiac disease
• Undergone cardiopulmonary bypass for cardiac surgery
• Be admitted in PICU for post-operative care

Exclusion Criteria:

• Preterm infant (GA < 37 weeks) or weight less than 2 kg
• Patient who weaned off cardiopulmoanry bypass and required extracorporeal membrane oxygenator (ECMO) before leaving the operating room
• Patient who required emergency cardiac operation within 24 hour after hospitalization
• Patient who had significant residual left side outflow tract obstruction (e.g., coarctation of aorta, interrupted aortic arch) which defined by difference of SBP between upper and lower extremities more than 10 mmHg
• Patient who had already participated in another research project
• Patient who does not have both arterial line and central line catheter back from operating room
• Parents or legal guardian refuse to inform consent.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of participant who developed low cardiac output syndrome related poor outcomes within 24 hour post operation	the low cardiac output syndrome (LCOS) related poor outcomes was diagnosed if at least two of the following criteria were met within 24 hours postoperatively: clinical LCOS: prolonged capillary refill >3 seconds, systolic blood pressure <5th percentile for age and sex, persistent elevation of left atrial pressure >10 mmHg for at least 6 hours, and low urinary output (<1 mL/kg/hour) for at least 6 hours despite diuretic use; laboratory LCOS: persistently elevated lactate level (>2 mmol/L), metabolic acidosis with an increase in the base deficit (>4 mmol/L) for at least 6 hours consecutively; Vasoactive-inotropic score ≥20; any unplanned surgery or intervention, cardiac arrest, or utilization of ECMO; left ventricular fraction <50% on echocardiography	from time of subject was admitted to ICU until the 24 hour post operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ventilator days	number of the days subject was intubated and used mechanical ventilator after operation	from date of subject was admitted to ICU until the date of subject was extubated, assessed up to 28 days
inotrope days	number of the days subject was on inotropic medication after operation	from date of subject was admitted to ICU until the date of subject was free of inotropic drugs, assessed up to 28 days
length of stay in ICU	number of the days subject was stay in ICU after operation	from date of subject was admitted to ICU until the date of subject was discharge, assessed up to 28 days

Collaborators and Investigators

• Sponsor: Prince of Songkla University

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2021
• Primary Completion (Actual): December 21, 2023
• Study Completion (Actual): December 26, 2023

Study Registration Dates

• First Submitted: February 9, 2024
• First Submitted That Met QC Criteria: February 29, 2024
• First Posted (Estimated): March 5, 2024

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Metabolic Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Postoperative Complications; Heart Defects, Congenital; Hyperlactatemia
• Other Study ID Numbers: REC 64-299-1-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: This data might be analyzed in other project and also we need to submit the form of data sharing to local EC unit.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No